Pelacarsen for Cardiovascular Disease

Recruiting at 391 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Investigational drugs

Disqualifiers: Significant disorder, sensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

5700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for people who have already finished the earlier pelacarsen study (CTQJ230A12301) and want to continue treatment. It focuses on those with a history of heart attack, stroke, or other cardiovascular diseases.

Inclusion Criteria

Participants who have provided informed consent prior to initiation of any study-specific activities/procedures

Participants who have completed the parent study EOS visit while still on assigned investigational product

Exclusion Criteria

Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study

Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including conditions outlined in Table 6-3 and Table 6-5

Participants are receiving another investigational drug or device before the open-label treatment period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive pelacarsen 80 mg once a month to evaluate long-term safety and tolerability

36 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pelacarsen (TQJ230)

Trial Overview

The study gives ongoing access to pelacarsen (TQJ230) so researchers can monitor its long-term safety and how well people tolerate it. All participants receive the same treatment; there is no placebo group.

How Is the Trial Designed?

Group I: Pelacarsen (TQJ230) Experimental Treatment 1 Intervention

open-label pelacarsen 80mg

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD